WASHINGTON, D.C. — Bionpharma Inc. this week announced a voluntary recall of a single batch of Atovaquone Oral Suspension, 750mg per mL, due to contamination with Cohnella bacteria. This recall, conducted with the knowledge of the Food and Drug Administration (FDA), affects batch number 2310083, manufactured by CoreRx, Inc. and distributed nationwide between December 2023 and June 2024.
The contamination poses a significant risk to immunocompromised individuals, who may experience severe, life-threatening infections if exposed. Such infections could include inflammation of the heart or irreversible damage to soft tissues. Despite the severity of potential outcomes, Bionpharma has reported no adverse events related to this contamination thus far.
Atovaquone Oral Suspension is primarily used as a quinone antimicrobial drug to prevent pneumocystis jirovecii pneumonia in patients aged 13 and older. The affected batch, produced on October 26, 2023, and released on December 5, 2023, carries an expiration date of September 2025. It is packaged in HDPE white bottles, identifiable by the lot number on the side panel or carton bottom flap.
Bionpharma is actively informing distributors and customers via email and organizing the return or replacement of the affected products. Distributors and retailers are advised to halt distribution and remove the batch from active inventory immediately. Consumers who possess the affected product should cease use and return it to the purchase location.
For inquiries, consumers can contact Bionpharma at (888) 235-2466, weekdays from 9 AM to 5 PM EST, or via email at drugsafety@bionpharma.com. Those who have experienced problems potentially linked to the product should consult healthcare providers and report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.
This recall underscores Bionpharma’s commitment to consumer safety, emphasizing enhanced quality control measures to prevent future occurrences.
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